FDA Approves Oral Testosterone Replacement Therapy Tlando

The Food and Drug Administration (FDA) has approved Tlando™ (testosterone undecanoate), an oral treatment for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

The approval was based on data from a multicenter, open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT03242590), which evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients. Patients received Tlando 225mg orally twice daily with food for approximately 24 days; no titration was performed to adjust the dosage.

Results demonstrated that the trial met the primary endpoint with 80% (95% CI, 72-88) of patients achieving a 24-hour average serum testosterone concentration (Cavg0-24h) within the normal range of 300-1080ng/dL on the final visit of the study. The percentage of patients who received Tlando and had a maximum total testosterone concentration threshold less than or equal to 1620ng/dL, between 1944ng/dL and 2700ng/dL, and greater than 2700ng/dL at the pharmacokinetic visit were 82%, 5%, and 0%, respectively.

As for safety, Tlando carries a Boxed Warning regarding blood pressure increases that can increase the risk of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke and cardiovascular death. Due to this risk, Tlando should only be used for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. The most common adverse reactions reported with Tlando include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, increased weight, headache, and musculoskeletal pain.

Tlando is supplied as 112.5mg of testosterone undecanoate capsules; it is not substitutable with other oral testosterone undecanoate products.

Robert F. Apple, President and CEO of Antares Pharma, commented, “The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. […] We look forward to launching Tlando commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.”

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